Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002509
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
1999-11-01
Brief Title:
High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Poor-Prognosis Breast Cancer
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
HIGH-DOSE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE ETOPOSIDE AND CARBOPLATIN FOLLOWED BY RESCUE WITH AUTOLOGOUS BONE MARROW AND AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH POOR PROGNOSIS BREAST CANCER
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining peripheral stem cell transplantation with combinations of drugs may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation or autologous bone marrow transplantation in women with stage II breast cancer with eight or more positive axillary lymph nodes and in women with stage III or metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation or autologous bone marrow transplantation in women with stage II breast cancer with eight or more positive axillary lymph nodes and in women with stage III or metastatic breast cancer
Detailed Description:
OBJECTIVES I Investigate the curative potential of high-dose cyclophosphamide etoposide and carboplatin followed by autologous stem cell rescue in women with breast cancer considered incurable by conventional therapy II Observe the overall response rate survival rate and toxicity associated with this regimen
OUTLINE Prior to therapy patients undergo collection of peripheral blood stem cells PBSC on another protocol patients with marrow involvement undergo PBSC harvest only while all others may also undergo bone marrow harvest All patients receive cyclophosphamide etoposide and carboplatin over 4 consecutive days followed 3 days later by PBSC or bone marrow and granulocyte colony-stimulating factor Patients are followed for duration of remission and survival
PROJECTED ACCRUAL 100-200 patients will be entered
OUTLINE Prior to therapy patients undergo collection of peripheral blood stem cells PBSC on another protocol patients with marrow involvement undergo PBSC harvest only while all others may also undergo bone marrow harvest All patients receive cyclophosphamide etoposide and carboplatin over 4 consecutive days followed 3 days later by PBSC or bone marrow and granulocyte colony-stimulating factor Patients are followed for duration of remission and survival
PROJECTED ACCRUAL 100-200 patients will be entered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V92-0205 | None | None | None |
| TUHSC-1992 | None | None | None |